FDA Eases Rules For Bristol Myers' Cell Therapies For Blood Cancers

The U.S. Food and Drug Administration (FDA) approved label updates for Bristol Myers Squibb & Co.’s BMY CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) for large B cell lymphoma (LBCL) and other lymphomas and Abecma (idecabtagene vicleucel; ide-cel) for multiple myeloma.

In the first quarter of 2025, Bristol Myers Squibb reported Abecam sales of $103 million, up 26% year over year, and Breyanzi sales jumped 146% to $204 million.

The company said in a statement on Thursday that these label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved.

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The company says about 2 in 10 eligible patients receive it due to the confluence of complex logistical and geographic barriers affecting patients and providers.

The FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma across both labels.

These prolonged requirements burdened healthcare delivery systems and certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers.

Driving restrictions post-treatment have been reduced from eight weeks to two weeks. The requirement to remain within proximity of a healthcare facility after infusion has also been shortened from four weeks to two weeks.

The FDA has also approved the removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies.

The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies.

In April 2024, the FDA said it would now require boxed warnings, the highest safety-related caution for medications, for all chimeric antigen receptor (CAR) T-cell therapies. 

According to the agency, these blood cancer treatments may pose a risk of secondary cancers.

Price Action: BMY stock is trading higher by 0.40% to $46.84 last check Friday.

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